ARTICLE | Strategy

Paving the way

How Amgen, Sandoz IP battles may unleash a flood of Humira, Enbrel biosimilars

July 25, 2016 7:00 AM UTC

Amgen Inc. and the Sandoz unit of Novartis AG are charting a course that could create competitive U.S. markets for two of the biggest prizes in the biosimilars universe, AbbVie Inc.'s Humira adalimumab and Amgen's Enbrel etanercept, which together had U.S. sales of $13.4 billion in 2015.

Unanimous advisory committee endorsements for ABP 501, Amgen's version of adalimumab, and GP2015, Sandoz's etanercept, suggest the two companies have overcome the formidable scientific and regulatory hurdles to gaining the first FDA approvals for self-injectable biosimilars. ...